Objectives: Hospital acquired pressure ulcers (HAPU) are a serious patient safety concern, resulting in poor patient outcomes and high healthcare costs. We developed a patient-centred pressure ulcer prevention care bundle (PUPCB) with input from patients, nurses and other health professionals. The objective of this study was to test the effectiveness of this PUPCB on incidence of HAPU in at-risk hospitalised patients. Methods: This cluster randomised trial recruited tertiary hospitals with >200 beds in three Australian states. Patients were eligible if they were: ≥18 years old; at risk of PU because of limited mobility; expected to stay in hospital ≥48 hours and able to read English. Hospitals (clusters) were stratified in two groups by recent HAPU rates and randomised within strata. The PUPCB was multi-component, and was aimed at the patient and nurse. There were three messages for patients’ participation in PUP care: keep moving; look after your skin; and eat a healthy diet. These messages were delivered as one-to-one patient education using a DVD, poster and brochure as resources. Nurses in intervention hospitals were trained in partnering with patients in their PUP care. The statistician, recruiters, and outcome assessors were blinded to group allocation and interventionists blinded to the study hypothesis (tested at both the cluster and patient level). The primary endpoint, incidence of HAPU, was detected by daily skin inspection. Data collection occurred from June, 2014 to May, 2015. The trial was registered with the Australian New Zealand Clinical Trials Registry (registration number ACTRN12613001343796). Results: A total of eight hospitals and 200 patients per hospital were recruited and 799 patients per group analysed. The mean (±SD) time spent delivering the intervention to each patient was 9.5 ± 5.4 minutes. Cluster adjusted, patient level analysis controlled for potential confounders yielded an adjusted hazard ratio of 0·58 (95% CI: 0·25, 1·33; p = 0·198) in the PUPCB group. At the cluster level, the HAPU incidence rate in the PUPCB group was 9·6 per 1000 days and in the control group it was 20·1 per 1000 days, with an incidence rate ratio of 0·48 (95% CI: 0·33, 0·69; p < 0·0001). Conclusion: The evidence indicating effectiveness of our intervention is unclear with the patient level analysis showing a 42% average reduction in HAPU rate in the PUPCB group, however, confidence intervals indicate that there may be a reduction of 75% or an increase of 33% in HAPU rates. The PUPCB is simple to implement and based on current clinical practice guidelines.

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33rd International Society for Quality in Healthcare (ISQua) International Conference, Tokyo, Japan 16-19 October 2016